Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

PBX 2021-07-30

Sectum

Applicant Neauvia North America

K-Number K202780

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IPF 2021-07-30

PowerDot PD-01MT2 Muscle Stimulator

Applicant Smartmissimo Technologies Pte, Ltd.

K-Number K210938

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NKG 2021-07-30

Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal Fixation Systems: (Firebird Deformity Spinal Fixation System, Phoenix MIS Spinal Fixation System, Phoenix CDX MIS Spinal Fixation System, JANUS Midline Fixation Screws, Firebird NXG Spinal Fixation System, JANUS Fenestrated Screws), Connector System, FIREBIRD SI Fusion System

Applicant Orthofix, Inc.

K-Number K211710

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PKT 2021-07-30

Powersculp laser lipolysis system

Applicant Lotuxs Medtech (Suzhou) Co., Ltd.

K-Number K211402

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JTN 2021-07-30

Thermo Scientific Oxoid Cefiderocol Disc (30 µg) FDC30

Applicant Oxoid Limited (Part of Thermo Fisher Scientific)

K-Number K203700

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IYN 2021-07-30

Labat series Diagnostic Ultrasound System

Applicant Shenzhen Wisonic Medical Technology Co. , Ltd.

K-Number K210154

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GCJ 2021-07-30

Lab Bag with Fabric Pouch

Applicant Advanced Medical Design Co., Ltd.

K-Number K210248

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QAQ 2021-07-30

Acumen Hypotension Prediction Index, HemoSphere Advanced Monitoring Platform

Applicant Edwards Lifesciences, LLC

K-Number K203224

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FED 2021-07-30

Mini PCNL-System

Applicant Trokamed GmbH

K-Number K200770

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QLG 2021-07-30

FreeStyle Libre 2 Flash Glucose Monitoring System (with FreeStyle Libre 2 App)

Applicant Abbott Diabetes Care, Inc.

K-Number K201761

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NRY 2021-07-30

EMBOTRAP III Revascularization Device

Applicant Neuravi, Ltd.

K-Number K211338

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LZA 2021-07-30

Disposable Nitrile Examination Gloves

Applicant Shenzhen Shiqiao Science and Technology Co., Ltd.

K-Number K211264

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